SIMEOX 200 Airway Clearance Device
FDA 510(k) clearance K241091 · decided 2024-12-23
Clearance details
- K-number
- K241091
- Device name
- SIMEOX 200 Airway Clearance Device
- Applicant
- Inogen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-22
- Decision date
- 2024-12-23
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- SDT
- Device class
- 2
- Regulation number
- 868.5665
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIBRALUNG ACOUSTICAL PERCUSSOR (K133057) | Westmed, Inc. | 2014-05-23 |
| RESPIRONICS SIMPLYCLEAR DEVICE (K122111) | Respironics, Inc. | 2012-12-31 |
Recalls involving this device
No recalls on record reference this clearance.